Biotech Values

[DewDiligence]

AMGN NVS:

Osteonecrosis of the jaw (ONJ) has been a major "selling" point for Dmab up to this point.

We have to see the actual ONJ numbers (when this study is presented at a medical conference) to know how material this might be from a business standpoint. AMGN’s PR said D-mab was not statsig worse than Zometa on ONJ, so the worst case for AMGN is ruled out. If the ONJ % in the D-mab arm is higher than in the Zometa arm but both %’s are tiny, I think this will be a non-issue.

…overall survival and the time to cancer progression were the same tells me that this drug, while having an easier dosing frequency really doesn't offer everything we hoped for.

I don’t agree. Statsig superiority to Zometa on the primary and secondary SRE endpoints along with non-inferiority on OS and TTP strikes me as a very good outcome for AMGN. I have a hard time believing that anyone was expecting an even better outcome.

I think Fosamax went generic last year.

Bisphosphonates are one of the few drug classes where oral administration may be more of a drawback than an advantage. Fosamax’s esophageal side effects and awkward dosing restrictions make it unsuitable for many users. Moreover, Fosamax does not have a cancer indication.